RT Journal Article
SR Electronic
T1 Design Considerations for Development of Steam In-Place Sterilization Processes
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 8
OP 12
VO 35
IS 1
A1 Myers, Ted
A1 Chrai, Suggy
YR 1981
UL http://journal.pda.org/content/35/1/8.abstract
AB A process is described for the steam in-place sterilization of a closed system sterile holding tank assembled with product and vent filtration equipment. This process permits complete non-aseptic assembly of the system, thereby eliminating aseptic manipulations that may result in equipment contamination. The development of this system involved a detailed evaluation of equipment design and limitations on process operation. Additional studies were performed examining suitable methods for steam in-place sterilization of hydrophilic and hydrophobic filters.